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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold Method)

Manufactured by Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd, China - ndh-biotech.com 

Device identification number
1755
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 U/ml
Calibration
Not Evaluated
Crossreactivity
Evaluated
Fp
85.71 % IgM (5/105)
Fp
92.13 % IgG (10/127)
Fn
95.49 % IgG (6/133)
Fn
98.67 % IgM (6/125)
Precision
Evaluated
Accuracy
93.85 % (IgG)
Accuracy
90.87 % (IgM)
Reproducibility
Evaluated
Reproducibility
Evaluated
Robustness
Not Evaluated
Clinical Sensitivity
92.13 % (IgG)
Clinical Sensitivity
85.71 % (IgM)

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements